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Safety and Efficacy of Zoledronic Acid in children with Osteogenesis Imperfecta
Insights
Zoledronic acid effectively treats osteogenesis imperfecta (OI) in children, significantly reducing fracture rates and improving bone mineral density (BMD) with minimal side effects.
Area of Science:
- Pediatric Endocrinology
- Orthopedics
- Pharmacology
Background:
- Osteogenesis imperfecta (OI) is a genetic disorder characterized by brittle bones.
- Bisphosphonates (BPs) are a class of drugs used to treat bone diseases.
- Assessing the efficacy and safety of BPs in pediatric OI is crucial for treatment optimization.
Purpose of the Study:
- To evaluate the efficacy and safety of zoledronic acid in children diagnosed with osteogenesis imperfecta (OI).
Main Methods:
- A descriptive study was conducted from January 2011 to December 2020 at the National Institute of Child Health, Karachi, Pakistan.
- Eighty-two children with OI received zoledronic acid intravenously at a dose of 0.05 mg/Kg/day for a median of 60 months.
- Patients were monitored for short-term side effects and assessed every 3-6 months for fracture frequency, bone pain, and bone mineral density (BMD) via DEXA scan.
Main Results:
- Zoledronic acid treatment led to a significant decrease in the annual fracture rate from 2.8 to 0.2 (P<0.001).
- Bone mineral density (BMD) Z-scores improved significantly, indicating enhanced bone strength.
- Adverse events were minimal, primarily consisting of transient fever (13.4%) and flu-like illness (2.4%), with no observed long-term complications like osteonecrosis of the jaw or ocular issues.
Conclusions:
- Zoledronic acid is a safe and effective treatment for pediatric osteogenesis imperfecta (OI).
- The therapy demonstrates significant improvements in bone mineral density (BMD) and a marked reduction in fracture incidence.
- Minimal short-term and long-term side effects support its use in managing OI in children.
Objective:
To evaluate the efficacy and safety of zoledronic acid in children with osteogenesis imperfecta (OI).
Study Design:
Descriptive Study.
Place And Duration Of Study:
National Institute of Child Health, Department of Endocrine and Diabetes, Karachi, Pakistan, from January 2011 to December 2020.
Methodology:
Children, with OI registered for the treatment, were included. Zoledronic acid was given to them by intravenous infusion over 30 minutes with a dose of 0.05 mg/Kg/day for a median duration of 60 (24-96) months. To ensure safety, patients were kept for 24 hours after dose administration to monitor any short-term side effects. The patients were assessed after every 3-6 months for frequency of fracture, bone pain, and BMD.
Result:
Out of 82 children [40 females (48.8%) and 42 males (51.2%)], 11 patients (13.4%) had fever and 2 patients (2.4%) had flu-like illness. No other side effects were observed. The annual fracture rate decreased overall from 2.8±1.5 to 0.2±0.5 (˂0.001) in both males (2.6±1.3 to 0.1±0.4) and females (3.1±1.7 to 0.2±0.6). Z-score on DEXA scan showed improvement in BMD overall (-3.9±2.0 to 2.2 ±1.7), in males (-3.7±1.9 to -2.1±1.7) and in females (4.1±2.1 to -2.3±1.8). There were no other long-term side effects like ocular problems, osteonecrosis of the jaw, and delayed healing of the fractures.
Conclusion:
Zoledronate use in children is associated with minimal short-term and long-term side effects with a significant improvement in BMD and decline in fracture rate.
Key Words:
Osteogenesis imperfecta (OI), Bisphosphonates (BPs), DEXA scan, Bone mineral density (BMD).
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